GUEST COLUMNISTS

• The Future Of Regenerative Medicine: A Macro View On Emerging Applications

  Part three of a three-part series on the future of regenerative medicine explores how regenerative medicine will help to improve quality of life in line with continued rise in global average life expectancy.

• Are You At Risk For An FDA ClinicalTrials.gov-Related Monetary Penalty?

  The FDA has historically not initiated formal actions to enforce the statutory requirements to register and provide clinical trial data to the ClinicalTrials.gov data bank. However, industry is now on notice that the FDA is about to change its approach.

• Mapping The Development Of A Biosimilar Candidate: Analytical & Regulatory Decisions

  This article, the first in a two-part series, details the biosimilar development path to identify and evaluate critical quality attributes for both the candidate biosimilar and the reference product, along the regulatory timeline.

• Forecasting The Extracorporeal Membrane Oxygenation (ECMO) Market In The Wake Of COVID-19

  This article will explore how COVID-19, along with key clinical trials, will ultimately change the ECMO market in future years through an assessment of high-, mid-, and low-level adoption scenarios, and how this market will change for pandemics in the future.

• Mammalian Biomanufacturing Industry Supply & Demand Trends

  While capacity will increase over the next five years, demand for capacity, pandemic aside, will increase at a slightly faster rate, allowing for some short-term loosening of capacity constraints, but after 2024, capacity tightening may occur.

• Biologics Manufacturing In China: Competition Heats Up Among CMOs & Their Clients

  Significant growth of outsourced commercial-scale manufacturing is projected for the near future in China, though certain bottlenecks remain.

• Federal Circuit To Decide Limits On Functional Claiming Of Isolated Monoclonal Antibodies

  Can a patent claim millions of different antibodies based on their function alone? Tens of thousands? Hundreds? What if the patent gives a plug-and-play road map to make and evaluate the antibodies through routine testing? Whatever the CAFC’s answer, one thing is sure: It will affect how biologic innovators use functional claiming and whether patentees or challengers are more likely to win future lawsuits in the biologics and biosimilar arena. 

• How Do FDA, MHRA, & Russia’s Drug Inspectorate Evaluate & Escalate Inspection Findings?

  Representatives from the Russian Federation State Institute of Drugs and Good Practices, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their processes for evaluating and escalating inspection findings to determine if regulatory action is needed.